Environmental Agency Protection The Agency may issue, when it deter
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Environmental Agency Protection The Agency may issue, when it deter
AUTHENTICATEDv-; U.S. GOVERNMENT INFORMATION CPO Pf. 156 Environmental Protection Agency § 155.56 Interim decision. re gistra tion review The Agency may issue, when it deter mines it to be appropriate. an interim registration r eview decision before completing a registration review. Among other things, the interim reg istration review decision may require new risk mitigation measures, impose interim risk mitigation measures. identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assess ment and completing the registration review. A FIFRA 3(c)(2)(B) notice re quiring the needed data or information may precede. accompany, or follow issuance of the interim registration re view decision. The Agency will follow procedures in § 155.58 when issuing an interim registration review decision . § 155.57 Registration review decision. A registration review decision is the Agency's determ ination whether a pes ticide meets, or does not meet, the standard for registration in FIFRA. final interim decision on a registration review case . (4) Specify proposed labeling chang·es; and (5) Identify deadlines that; it intends to set for completing any required ac tions. (c) After considering any comments on the proposed decision, the Agency will issue a registration review deci sion or interim registration review de cision . This decision will include an ex planation of any changes to the pro posed decision and the Agency's re sponse to significant comments. The Ag·ency will publish a notice in the F EDERA L Rl,GISTER announcing the availability of a registration review de cision or interim registration review decision. The registration revi ew case docket wi ll remain open until all ac tions required in the final decision on the registration review case have been completed. (d) If the registrant fails t o take the action required in a registration review decision or interim registration review decision, the Agency may take appro priate action under FIFRA. § 155.58 Procedures for issuing a deci sion on a registration review case. (a) The Agency will publish a notice in the FEDERAL REGISTER announcing the availability of a proposed registra tion review decision or a proposed in terim registration review decision. At that time, the Agency will place in the pesticide's registration review docket the Agency's proposed decision and the bases for the decision. There will be a comment period of at least 60 calendar clays on the proposed decision. (b) In its proposed decision, the Agen cy will, among other things: (1) State its proposed findings with respect to the FIFRA standard for reg istration and describe the basis for such proposed findings. (2) Identify proposecl risk mitigation measures or other remedies as needed and describe the basis for such pro posed requirements. (3J State whether it believes that ad ditional data are needed and, if so, de scribe what is needed. A FIFRA 3(c)(2)(B) notice requiring such data may be issued in conjunction with a proposed or fi nal decision on the reg istration review case or a proposed or 61 PART 156-LABELING REQUIRE MENTS FOR PESTICIDES AND DE VICES Subpart A-General Provisions Sec. 156.3 Definitions. 156.10 Labeling requirements. Subparts B-C [Reserved] Subpart D-Human Hazard and Precautionary Statements 156.60 General. 156.62 Toxicity Category. 156.64 Signal word. 156.66 Child hazard warning. 156.68 First aid statement. 156 .70 Precauti onary statement s for human hazards. 156.78 Precautionary statements for phys ic:al or chemical hazards. Subpart E- Environmenta l Hazard and Precautionary Statements 156.80 General. 156 .85 Non-target organisms. Subparts F-G [Reserved] 40 CFR Ch. I (7-1-1 0 Edition) § 156.3 Subpart H-Container Label ing 156.140 Identification of container types. 156.144 Residue removal instructions-gen eral. 156.146 Residue removal instructions for nonrefillable containers-rigid con tainers with dilutable pesticides. 156.156 Residue removal instructions for re fillable containers. 156.159 Compliance date. Subparts 1-J [Reserved) Subpart K- Worker Protection Statements 156.200 Scope and applicability. 156.20:l Definitions. 156.204 Modification and waiver of requireInents. 156.206 General st atements. 156.208 Restricted-entry statements. 156.210 Notification-to-workers statements. 156.212 Personal protective equipment st atements. AUTHOR.l'l'Y: 7 U.S.C . 136-136y. Subpart A-General Provisions § 156.3 Definitions. Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition. as used in this part, the follo wing terms shall have the meanings set forth below. Dilu table means that the pesticide product's labeling all ows or requires the pesticide product to be mixed with a liquid diluent prior to applicat ion or use. Transport vehicle means a cargo-car rying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transpor tation of cargo by any mode. [73 FR 64224 , Oct. 29, 2008] § 156.10 Labeling requirements. (a) Genera l- (1) Contents of the label. Every pesticide product shall bear a label containing the information speci fied by the Act and the regulations in this part. The contents of a label must show clearly and prominently the fol lowing: (i ) The name , brand, or trademarlr under which the product is sold as pre scribed in paragraph (b) of this section; (ii) The name and address of the pro ducer, registrant, or person for whom produced as prescribed in paragraph (c) of this section; (iii) The net contents as prescribed in paragraph (d) of this section; (iv) The product registration number as prescribed in paragraph (e) of this section; (v) The producing establishment number as prescribed in paragraph (f) of this section; (vi) An ingredient statement as pre scribed in paragraph (g) of this section; (vii) Hazard and precautionary state ments as prescribed in subpart D of this part for human and domestic ani mal hazards and subpart E of this part for environmental hazards. (viii) The directions for use as pre scribed in paragraph (i) of this section; and (ix) The use classification(s) as pre scribed in paragraph (j) of this section. (2) Prominence and legibility. (i) All words, statements, graphic representa tions, designs or other information re quired on the labeling by the Act or the regulations in this part must be clearly legible to a person wi t h normal vision, and must be placed with such conspieuousness (as compared with other words, statements, designs, or graphic matter on the labeling) and ex pressed in such terms as t o render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (ii) All required label text must: (A) Be set in 6-point or larger type; (B) Appear on a clear contrasting background; and (C) Not be obscured or crowded. (3) Language to be used. All required label or labeling text shall appear in the English language. However, the Ag·ency may require or the applicant may propose additional text in other languages as is considered necessary to protect the public. When additional text in another language is necessary, all labeling requirements will be ap plied equally to both the English and other-lang·uage versions of the label ing. (4 ) Placement of Label- (i ) General. 'l'he label shall appear on or be securely attached to the immediate container of the pesticide product. For purposes of this section, and the misbranding pro visions of the Act, "securely attached" 62 § 156.10 Environmental Protection Agenc y shall mean that a label can reasonably be expected to remain affixec1 during the foreseeable conditions and period of use. If the immediate container is enclosed within a wrapper or outside container through which the label can not be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold. (ii) Tank cars and other bulk con tainers- (A) Transportation. While a pes ticide product is in transit, the appro priate provisions of 49 CFR parts 170- 189, concerning the transportation of hazardous materials, and specifically those provisions concerning the label ing·, marking and placarding of haz ardous materials and the vehicles car rying them , define the basic Federal requirements. In addition, when a ny registered pest icide product is trans ported in a tank car, tank truck or other mobile or portable bulk con tainer, a copy of the accepted label must be attached to the shipping pa pers, and left with the consignee at the time of delivery. (B) Storage. When pesticide products are stored in bulk containers, whether mobile or stationary, which remain in the custody of the user, a copy of the label of labeling, including all appro priate directions for use , shall be se curely attached to the container in the immediate vicini ty of the discharge control valve. (5) False or misleading statemen ts. Pur suant to section 2(q)(1)(A) of the Act, a pesticide or a device declared subject to the Act pursuant to §152.500, is mis branded if its labeling is false or mis leading in any particular including both pesticidal and non-pesticidal claims. Examples of statements or rep resentations in the labeling which con stitute misbranding include: (i) A false or misleading· statement concerning the composition of the product; (ii ) A false or misleading statement concerning the effectiveness of the product as a pesticide or device ; (iii) A fal se or misleading statement about the value of the product for pur poses other t han as a pesticide or de vice; (iv) A false or misleading comparison with other pesticides or devices; (v) Any statement directly or indi rectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Government; (vi) Th e name of a pesticide which contains two or more principal active ingredients if the name suggests one or more but not all such principal active ingredients even though the names of the other ingredients are st ated else where in the labeling; (vii) A true statement used in such a way as to give a false or misleading im pression to the purchaser; (viii) Label disclaimers which negate or detract from labeling stat ements re quired under the Act and these r egul a tions: (ix) Claims as to the safety of the pesticide or its ingredients, including statements such as " safe," " nonpoi sonous, " "noninjurious," ' 'harmless" or " nontoxic to humans and pets" with or without such a qualifying phrase as "when used as directed"; and (x) Non-numerical and/or compara tive statements on the safety of the product, including but not limited to: (A) " Contains all natural ingredi ents" ; (B) ·'Among the least toxic chemicals kn own" (C) " Pollution appr oved" (6) Final printed labeli ng. (i) Except as provided in paragraph (a)(6)(ii) of this section, final printed labeling must be submitted and accepted prior to reg istration. However, final printed label ing need not be submitted until draft label texts have been provisionally ac cepted by the Agency. (ii) Clearly legible reproductions or photo reductions will be accepted for unusual labels such as those silk screened directly onto glass or metal cont ainers or large bag or dr um labels. Such reproductions must be of micro film reproduction quality. (b) Name, brand, or trademark. {1) The name , brand, or trademark under whi ch the pesticide product is sold shall appear on the front pa nel of the label. (2) No name, brand, or trademark may appear on the label whi ch: (i) Is false or misleading, or 63 § 156.10 40 CFR Ch. I (7-1-10 Edition) (ii) Has not been approved by the Ad ministrator through registration or supplemental registration as an addi tional name pursuant to § 152.132. (c) Name and address of producer, registrant, or person for whom pro duced. An unqualified name and ad dress given on the label shall be consid ered as the name and address of the producer. If t h e registrant's na me ap pears on the la bel and the registrant is not the producer, or if the name of the person for whom the pesticide was pro duced appears on the label, it must be qualified by appropriate wording such as " Packed for* * *," "Distributed by * * *, " or "Sold by * * *" to show that the name is not that of the producer. tion or sale of the pesticide. As re quir ed in paragraph (a){1)(iii) of this sect ion, the net contents must be shown clearly and prominently on the label. (e) Product Tegistration numba . The registration number assigned to the pest icide product at the time of reg istration shall appear on the label, pre ceded by the phrase "EPA Registration No .," or the phrase " EPA Reg. No. " T he registration number shall be set in type of a size and style similar to other print on that part of the label on which it appears and shall r un parallel to it. The registration number and the re quired identifying phrase shall not ap pear in such a manner as t o suggest or (d) Net weight or measure of contents. imply recommendation or en dorsement (1) The net weight or measure of con of the product by the Agency . (f) Producing establishment's Tegistra tent shall be exclusive of wrappers or other materials and shall be the aver tion number . The producing establish age content unless explicitly stated as ment registration number preceded by the phrase "EPA Est." , of the final es a minimum quantity. (2) If the pesticide is a liquid. the net tablishment at which the pr oduct was content statement shall be in terms of produced may appear in a n y suitable liquid measure at 68 °F (20 °C) and shall location on the label or immediate con be expr essed in conventional American tainer. It must appear on the wra pper units of fluid ounces, pints, quarts, and or outside container of the package if the EPA establishment regi stration gallons. (3) If the pesticide is solid or semi number on the immediate container solid, viscous or pressurized, or is a cannot be clearly read through such mixture of liquid and solid, the net wra pper or container. For a pesticide content statement shall be in terms of product packaged in a refillable con weight expressed as avoirdupois pounds tainer, an appropriately sized area on the label may be left blank after the and ounces. (4) In all cases, net content shall be phrase "EPA Est." to allow the EPA stated in terms of the largest suitable establishment registration number to units, i.e. , ''1 pound 10 ounces" rather be marked in by the refiller according to 40 CFR 165.65(h) or 165.70(i) prior to than " 26 ounces." (5) In addition to the required units dist ribution or sale of the pesticide. (g) Ingredient statement-(1) General. specified, net content may be expressed The label of each pesticide product in metric units. (6) Variation al) ove minimum content must bear a statement whi ch contains or around an average is permissible the name and percentage by weight of only to the extent that it r epr esents each active ingredient, the total per deviation unavoidable in good manu centage by weight of all inert ingredi facturing practice. Variation below a ents; and if the pesticide contains ar stated minimum is not per mitted. In senic in any form , a statement of the no case shall the average content of percentages of total and water-soluble the packages in a shipment fall below arsenic calculated as elemental ar senic. The active ingredients must be the stated average content. (7) For a pesticide product packaged designated by the term "active ingredi in a refillable container, an appro ents" and the inert ingredients by the priately sized area on the label may be term " inert ingredients," or the sin left blank to allow the net weight or gular forms of these terms when appro measure of content to be marked in by priate. Both t erms shall be in the same the refiner according to 40 CFR type size, be aligned to the same mar 165.65(h) or 165.70(i) prior to distribu gin and be equally prominent. The 64 Environmental Protection Agency § 156.10 statement " Inert IngTedients, none " is not required for pesticides which con tain 100 percent active ingredients. Un less the ingredient statement is a com plete analysis of the pesticide, the term "analysis" shall not be used as a heading for the ingredient statement. batches, the value stated for each ac tive ingredient shall be the lowest per centage which may be present. (6) Deterioration. Pesticides which change in chemical composition sig nificantly must meet the following la beling requirements: (2) Position of ingTedient statement. (i) (i) In cases where it is determined The ingredient statement is normally that a pesticide form ulation changes required on the front panel of the label. chemical composition significantly, If there is an outside container or the product must bear the following wrapper through which the ingredient statement in a prominent position on statement cannot be clearly read, the the label: "Not for sale or use after ingredient statement must also appear [date].'' on such outside container or wrapper. (ii) The product must meet all label If the size or fo rm of the package claims up to the expiration time indi makes it impracticable to place the in cated on the label. gredient statement on the front panel (7) Inert ingredients . The Adminis of the label. permission may be granted trator may require the name of any for the ingredient statement to appear inert ingredient(s) to be list;ed in the elsewhere. ingredient statement if he determines (ii) The text of the ingredient state that such ingredient(s) may pose a haz ment must run parallel with other text ard to man or the environment. (h) [Reserved] on the panel on which it appears, and (i) DiTections joT Use-(1) General re must be clearly distinguishable from and must not be placed in the body of quirements- (i) Adequacy and clarity of directions. Directions for use must be other text. stated in terms which can be easily (3) Names to be used in ingredient state ment. The name used for each ingre read and understood by the average dient shall be the accepted common person likely to use or to supervise the name. if there is one, followed by the use of the pesticide. When followed, di chemical name. The common name rections must be adequate t o protect may be used alone only if it is well the public from fraud and from per known. If no common name has been sonal injury and to prevent unreason established, the chemical name alone able adverse effects on the environ shall be used. In no case will the use of ment . (ii ) Placement of directions for use. Di a trademark or proprietary name be permitted unless such name has been rections may appear on any portion of accepted as a common name by the Ad the label provided that they are con ministrator under the authority of sec spicuous enough to be easily read by tion 25(c)(6). the user of the pesticide product. Di (4) Statements of percentages. The per rections for use may appear on printed centages of ingredients shall be stated or graphic matter which accompanies in terms of weight-to-weight. The sum the pesticide provided that: (A) If required by the Agency, such of percentages of the active and the inert ingredients shall be 100. Percent printed or graphic matter is securely ages shall not be expressed by a range attached to each package of the pes of values such as " 22-25%. " If the uses ticide, or placed within the outside of the pesticide product are expressed wrapper or bag; (B) '.rhe label bears a reference to the as weight of active ingredient per unit area, a statement of the weig·ht of ac directions for use in accompanying tive ingredient per unit volume of the leaflets or circulars, such as " See di pesticWe formulation shall also appear rections in the enclosed circular:" and (C ) The Administrator determines in tlle ingredient statement. (5) Accuracy of stated percentages. The that it is not necessary for such direc percentages given shall be as precise as tions to appear on the label. (ii i ) Exceptions to Tequirernent for direc possible reflecting good manufacturing practice. If there may be unavoidable tion for use. (A) Detailed directions for variation between manufacturing use may be omitted from labeling- of 65 40 CFR Ch. I (7-1·-10 Edition) § 156.10 pesticides which are intended for use only by manufacturers of products other than pesticide products in their r egular manufacturing processes, pro videcl that: (1) The label clearly shows that the product is intended for use only in manufacturi ng processes and specifies the type(s) of products involved. (2) Adequate information such as technical clata sheets or bulletins. is available to the trade specifying tho type of product involved and its proper use in manufacturing processes; (3) The product will not come into the hands of the general public except after incorporation into finished prod ucts; and (4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment. (B) Detailed directions for use may be omitted from the labeling of pes ticide products for which sale is lim ited to physicians, veterinarians. or druggists, provided that: <1) The label clearly states that the product is for use only by physicians or veterinarians; (2 ) The Admin istrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment; and (3) 'I'he product is also a drug and regulated under the provisions of the Federal Food, Drug and Cosmetic Act. (C) Detailed directions for use may be omitted from the labeling of pes ticide products which are intended for use only by formulators in preparing pesticides for sale to the public, pro vided that: (1) There is information readily available to the formulators on the composition, t oxicity, methods of use, applicable restrictions or limitations, and effectiveness of the product for pesticide purposes; (2) 'rhe label clearly states that the product is intended for use only in manufacturing, formulating, m1xmg, or r epacking for use as a pesticide and specifies the t ype(s) of pesticide prod ucts involved; (3) The product as finally manufac tured, formulated, mixed, or repack aged is registered; and (4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment. (2) Contents of Directions for Use. The direct ions for use shall include the fol lowing, under the headings " Directions for Use " : (i ) The statement of use classifica tion as prescribed in paragraph (j) of this section immediately under the heading " Directions for Use. " (ii) Immediately below the statement of use classification, the sta.tement " It is a violation of Federal law to use this product in a manner inconsistent with its labeling." (iii) The site(s) of application, as for example the crops, animal8, areas, or objects to be treated. (iv) The target pest(s) associated with each site. (v) The dosage rate assoeiated with each site and pest. (vi) The method of application, in cluding instructions for dilution, if re quired, and type(s) of application appa ratus or equipment required. (vii ) The frequency and timing of ap plications necessary to obtain effective results without causing unreasonable adverse effects on the environment. (viii) Worker protection statements meeting the requirements of subpart K of this part. (ix) Specific directions concerning the storag·e, residue removal and dis posal of the pesticide and its container, in accordance with subpart H of this part. These instructions must be grouped and appear under the heading, "Storage and Disposal." Th is heading must be set in type of the same min imum sizes as required for the child hazard warning. (See table in § 156.60(b)) (x) Any limitations or r est rictions on use required to prevent un reasonable adverse effects, such as: (A) Required intervals between appli cation and harvest of fo od or feed crops. (B) Rotational crop restrictions. (C) Warnings as required against use on certain crops, animals, ob jects, or in or adjacent to certain areas . (D) For total release fogg·ers as de fined in § 156.78( d)(l), the following 66 § 156.60 Environmental Protection Agency statements must be included in the ''Directions for Use." DO NOT use more than one fogger per room. DO NOT use in small, enclosed spaces such as closets, cabinets. or under counters or tables. Do not use in a room 5 ft.x5 ft. or smaller; instead, allow fog to enter from other rooms. Turn off ALL ignition sources such as pilot lights (shut off gas valves) , other open f1ames . or running electrical ap pliances that cycle off and on (i.e .. refrig erators, thermostats, etc.). Call your gas utility or management company if you need assistance with your pilot lights." (E) For restricted use pesticides, a statement that the pesticide may be applied under the direct supervision of a certified applicator who is not phys ically present at. the site of application but nonetheless available to the person applying- the pesticide, unless the Agency has determined that the pes ticide may only be applied under the direct supervision of a certified appli cator who is physically present. (F) Other pertinent information which the Administrator determines to be necessary for the protection of man and the environment. (j) Statement of use classification. Any pesticide product for which some uses are cla ssified for general use and others for restricted use shall be separately labeled according to the labeling stand ants set forth in this subsection, and shall be marketed as separate proclucts with different registration numbers, one bea ring- directions only for general use(s) and the other bearing directions for restricted use(s) except that, if a product has both restricted use(s) and general use(s), both of these uses may appear on a product labeled for re stricted use. Such products shall be subject to the provisions of paragraph (j)(2) of this section. (l) General Use Classification. Pes ticide products bearing directions for use(s) classified general shall be la beled with the exact words "General Classification" immediately below the heading " Directions for Use." And ref erence to the general classification that suggests or implies that the gen eral utility of the pesticide extends be yoml those purposes and uses contained in the Directions for Use will be consid ered a false or misleading statement under the statutory definitions of mis branding. (2) Uestricted Use Classification. Pes ticide products bearing direction for use(s) cla ssified restricted shall bear statements of restricted use classifica tion on the front panel as described below; (i) Front panel statement of restricted use classification. (A) At the top of the front panel of the label , set in type of the same minimum sizes as required for human hazard signal words (see table in paragraph (h)(l)(iv) of this sec tion), and appearing with sufficient prominence relative to other t ext and graphic material on the fron t panel to make it unlikely to be overlooked under customary conditions of pur chase and use , the statement "Re strict ed Use Pesticide" shall appear. (B) Directly below this statement on the front panel, a summary statement of the terms of restriction imposed as a precondition to registration shall ap pear. If use is restricted to certified ap plicators, the foll owing stat ement is required: "For retail sale to and use only by Certified Applicators or per sons under their direct supervision and only for those uses covered by the Cer tified Applicator's certification." If, however, other regulatory r estrictions are imposed, the Administrator will de fine the appropriate wording- for the t erms of restriction by regulation . [40 F'R 28268, July 3, 1975; 40 I<'R 3;:329, Aug. 1. 1975; 40 FR 36571. Aug. 21, 1975. as amended at; 43 VR 5786, ]<'elJ. 9, 1978. Redesignated and amended at 53 FR 15991, 15999, May 4, 1988; 57 F'R 38146, Aug. 21, 1992; 60 FR 32096 , June 19, 1995; 63 FR 9082, Feb. 23, 1998; 66 FR 64764, Dec. 14. 2001; 71 FR 47420, Aug. 16, 2006; 73 FR 75596. Dec. 12, 2008] Subparts B-C [Reserved] Subpart 0-Human Hazard and Precautionary Statements SOURCE: 66 J<' R 64764, Dec. 14, 2001, unless oth erwise noted. § 156.60 General. Each product label is required to bear hazard and precautionary statements for humans and domestic animals (if applicable) as prescribed in this sub part. Hazard statements describe the type of hazard that may occur, while precautionary statements will either 67 § 156.62 40 CFR Ch. I (7- 1-10 Edition) direct or inform the user of actions to take to avoid the hazard or mitigate its effects. TYPE SIZE S FOR FRONT PANEL WARNING STATEMENTS Point Size {a) Location of statements-(l) Front panel statements. The signal word, child Size of Label Front Panel (Square Inches) hazard warning, and, in certain cases, the first aid statement are required to appear on the front panel of the label, and also in any supplemental labeling intended to accompany the product in distribution or sale. (2) Statements elsewhere on label. Haz ard and precautionary statements not required on the front panel may appear on other panels of the label , and may be required also in supplemental label ing. These include, but are not limited to, the human hazard and pre cautionary statemen t s, domestic ani mal statements if applicable, a Note to Physician , and physical or chemical hazard statements. (b) Front ~0~~1 (All Capital Letters) 5 and under ............... ....... . Over5to10 ............ ................................ . Over 10 to 15 . Over 15 to 30 6 10 12 14 Over 30 .. . .. . 18 Child Hazard Warn ing 6 6 8 10 12 (2) Other required statements. All other hazard and precautionary statements must be at least 6 point type. § 156.62 Toxicity Category. This section establishes fo ur •roxicity Categories for acute hazards of pes ticide products, Category I being the highest toxicity category . Most human hazard, precautionary statements, and human personal protective equipment statements are based upon t h e Toxicity Category of the pesticide product a s sold or distributed. In addition, tox icity categories may be used for regu latory purposes other than labeling, such as classification for restricted use and requirements for child-resistant packaging. In certain cases, statements based upon the Toxicity Category of the product as diluted for use are also permitted. A Toxicity Category is a s signed for each of five types of acute exposure, as specified in t he table in this paragraph. Placemen t and prominence- (l) panel stat ements. All required front panel warning statements shall be gTouped together on the label, and shall appear with sufficient promi nence r elative to other front panel text a nd graphic material to make them un likely to be overlooked under cus tomary conditions of purchase and use. The table below shows the m inimum type size requirements for the front panel warning statements for various front panel sizes. ACUTE TOXICITY CATEGORIES FOR PESTICIDE PRODUCTS Hazard Indicators Oral LDso . Dermal LD so ....... Inhalation LC 50 Eye irritation . Skin irritation . *156.64 . II I Up to and including 50 mg/kg Up to and incl uding 200 mg/kg Up to and including 0.2 mg/l iter Corrosive; corneal opacity not reversible within 7 days Corrosive Il l IV >50 thru 500 mglkg >500 thru 5,000 mglkg >5,000 rnglkg >200 thru 2000 mglkg >2000 thru 20,000 mgl kg >2 thru 20 mg/liter >20,000 mg/kg No corneal opacity; ir ritation reversible wi thin 7 days No irritation Moderate irritation at Mild or slight irritation at 72 hours >0.2 thru 2 mg/titer Comeal opacity re versible within 7 days; irri tation per sisting fo r 7 days Severe irritation at 72 hours 72 hours >20 mg/li ter word, reflecting- the highest Toxicity Categ-ory (Category I is t he highest toxicity category) to which the procluct is assignecl by any of the fi ve routes of ex posure in §156.62 . The sig·nal word Signal word. (a) nequ i rement . Except as provided in parag-raph (aJ(4), each pesticide product must bear on the fro nt panel a signal 68 Environmental Protection Agency § 156.68 must also appear together with the heading for the human precautionary statement section of the labeling (see § 156.70). (1) Toxicity Category I. Any pesticide product m eeting the criteria of Tox icity Category I for any route of expo sure must bear on the front panel the sig·nal word "DANGER." In addition. if the produet is assigned to T oxicity Category I on the basis of its oral, in halation or dermal toxicity (as distinct from skin and eye irri tation), the word "Poison" must appear in red on a back ground of distinctly contrasting color, and the skull and crossbones symbol must appear in immediate proximity to the word ' ·Poison." (2) Toxicity Category II. Any pesticide product meeting the criteria of Tox icity Category II as the highest cat egory by any route of exposure must bear on the front panel the signal word " WARNING." (3) Tox'icity Category III. Any pesticide product m eeting the criteria of Tox icity Category III as the highest cat egory by any route of exposure must bear on the front panel the signal word " CAUTIO N. " (4) Toxicity Category IV. A pesticide product m eeting the criteria of Tox icity Category IV by all routes of expo sure is not required t o bear a signal word. If a signal word is used, it must be " CAUTION." (b) Use of signal words. In no case may a product: (1) Bear a signal word reflecting a higher Toxicity Category than indi cated by the route of exposure of high est toxicity, unless the Agency deter mines that such labeling is necessary to prevent unreasonable adverse effects on man or the environment: (2) Bear a signal word reflecting a lesser Toxicity Category associated with a diluted product. Although pre cautionary statements for use dilu tions may be included on label , the sig nal word must reflect the toxicity of the product as distributed or sold; or (3) Bear different signal words on dif ferent parts of the label. dren." That statement, or any alter native statement approved by EPA, must appear on a separate line in close proximity to the signal word, if re quired . The statement is required on Toxicity Category IV products that do not otherwise require a signa l word. (b) In its discretion, EPA may waive the requirement, or require or permit an a lternative child hazard warning, if: (1) The applicant can demonstrate that the likelihood of exposure of chil dren to the pesticide during distribu tion, marketing, storage or use is re mot e (for example, an industrial use product); or (2) The pesticide is approved for use on children (for example, a n insect re pellent). (c) EPA may approve an alternative child hazard warning that more appro priately reflects the nature of the pes ticide product to which children may be exposed (for example, an impreg nated pet collar) . In this case , EPA may also approve placement on other than the front panel. § 156.68 First aid statement. Product as sold and distributed . Each product must bear a first aid statement if the product has systemic effects in Category I, II, or III, or skin or eye irritat ion effects in Category I or II. (b) Product as diluted for use. If the product labeling bears directions for dilution with water prior to use, the label may also include a statement de scribing how the first aid measures may be modified for the diluted prod uct. Such a statement must reflect the Toxicity Category(ies) of the diluted product, based upon data for the route of exposure (or calculations if appro priate) . If the labeling provides for a rang·e of use dilutions , only that use di lution representing the h ighest con centration allowed by labeling may be used as the basis for a stat ement per taining to the diluted product. The statement for a diluted product may not substitute for the sta.tement for the concentrate , but augments the in formation provided for the con § 156.66 Child hazard warning. centrate. (c) Heading. The heading of the state (a) Each pesticide product must bear on the front panel of the label the ment may be " First Aid" or "State statement "Keep Out of Reach of Chil ment of Practical Treatment." 69 (a) § 156.70 40 CFR Ch. I (7-1-1 0 Edition) (d) Location of first aid statement. 'rhe first a id statement must appear on the front panel of the label of all products assig-ned to Toxi city Category I by a n y route of exposure. Upon review, the Ag·ency may permit reasonable vari ations in t he placement of the first aid statement if a reference such as ' ·See first aid statement on back panel" ap pears on the front panel. The first aid statement for products assigned to Toxicity Categories II or III may ap pear on any panel of the label. heading if domestic animals will not be exposed to the product. (b) Content of statements. When data or other information show that an acute hazard may exist to h umans or domesti c animals, the label must bear precautionary statements describing the particular hazard , the route(s) of exposure and the precauti ons to be taken to avoid accident, inj ury or toxic effect or to mitigate the effect . The precautionary paragraph must be im mediately preceded by the appropriate signal word. § 156.70 Precautionary statements for human hazards. (c) Typical precautionary statements. (a) Requirement. Human hazard and The table below presents typical haz precautionary statements as required ard and precautionary statements. Spe must appear together on the label or cific statements pertaining t o the haz labeling under the general heading ards of the product and its uses must ''Precautionary Statements" and be approved by the Agency. With Agen under appropriate subheadings similar cy approval, statements may be aug to " Humans and Domestic Animals," mented to reflect th e hazards and pre ·'Environmental Hazards" (see subpart cautions associated with the product as E of t his part) and ·'Physical or Chem diluted for use. Refer to § 156.68(b) for ical Haza rds." The phrase " and Domes requirem ents for use dilution state tic Animals" may be omitted from the ments. TYPICAL HUMAN HAZARD AND PRECAUTIONARY STATEMENTS Toxicity Category Systemic effects (oral, dermal, in halation toxicity) (poisonous) if swallowed [inhaled or absorbed through skin]. Do no! breathe vapor [dust or spray mist]. Do not get I Fatal in eyes, on skin, or on clothing. [Front panel first aid statement required .] May be fatal if swallowed, [in II haled or absorbed through the skin]. Do not breathe vapo rs [dus t or spray mist] . Do not gel in eyes , on skin, or on clothing. [Appropriate first aid statem ent required.] Ill Harmfu l if swallowed [inha led or absorbed through the skin] . Avoid breath ing vapors [dusl or Irritation effects (skin and eye} Corrosive, causes eye and skin damage [or skin irritation]. Do not get in eyes on skin, or on clothing. Wear goggles or face shield and rubber gloves when handling . Harmful or fatal if swallowed. [Front panel first aid statement requir ed .] Sens itizer (The re are no cat- egories of sensitization.) If product is a sensitizer: Pro longed or frequently repeated skin contact may cause allergic reactions in some individual s. Causes eye [and skin] irritation. Do not get in eyes. on skin, or on clothing. Harmfu l if swal· lowed. [App ropria te first aid statement required.] Avoid contact with skin, eyes or clothing. spray mist]. Avoid contact with skin [eyes or clothing}. [Appro· priate first aid statement re- qui red.] IV No precautionary statements re· qui red No precautionary statements re· qui red. acteristics of the pesticide product a re required if a product meets t he criteria (aJ Requirement. Warning statements in this section. Warning statements on t he flammability or explosive char pert aining to other physical/chemical § 156.78 Precautionary statements for physical or chemica l hazards. 70 § 156.80 Environmental Protection Agency hazards (e.g., oxidizing potential , con ductivity, chemical reactions leading to production of toxic substances) may be required on a case-by-case basis. (b) Pressurized products. The table below sets out the required flamma bility label statements for pressurized products. FLAMMABILITY STATEMENTS FOR PRESSUR IZED PRODUCTS Flash poinVflame exten· sian of product - Flash point at or below 20 '-' F Required labeling statement Extremely flammable. Contents under pressure . Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to tempera· lures above 130 of may cause bursting. OR -Flashback at any valve opening -Flash point >20 "'F to 80 oF Flammable. Contents under pres· sure. Keep away from heat, sparks and open flame. Do not puncture or incinerate container . Exposure to temperatures above 130 "F may cause bursting. OR l ease the total contents in one oper ation, for the purpose of crea ting a per meat ing fog within a confined space to deliver the pesticide throughout the space. (2) If a pesticide product is a total re lease fogger containing a propellant with a flash point at or below 20 °F, then the following- special instructions must be added to the " Physical and Chemical Hazards" warning statement, in addition to any flammability state ment required by paragraph (b) of t his section: This product contains a hi ghly flam mable ingredient. It may cause a fire or explosion if not used properly. Fol low the Directions for Use on t his label very carefully. (3) A graphic symbol depicting fire , such as illustrated in this paragraph, or an equivalent symbol, must be dis playe d along· with the required lan guage adjoining the ·'Physical and Chemical Hazards" warning statement. The graphic symbol must be no smaller than twice the size of the first char act er of the human hazard signal word. - Flame extension more th an 18 in. long a t a distance of 6 in I rom the flame Art other pressurized products Contents under pressure. Do no t use or store near heat or open flame. Do not puncture or incin· erate container. Exposure to tem peratures above 130 °F may cause bursting. Hi ghly Flammable Ingredient Ingrediente Altamente Int1amable (c) Non-pressurized pro ducts. The table below sets out the required flamma bility label statements for non-pressur ized products. Subpart E-Environmental Hazard and Precautionary Statements SOURCE: 66 FR 64767, Flash point Extremely flamm able. Keep away from fire , spa rks and heated sur faces . Greater than 20 11 F to Flammable. Keep away from heat 80 °F Greater than 80 °F to 150 Of § 156.80 Required labeling statement At or below 20 "F Dec. 14. 2001, unless otherwise noted. FLAMMABILITY STATEMENTS FOR NON PRESSURIZED PRODUCTS General. (a) Requirement. Each product is re quired to bear hazard and pre cau t ionary statements for environ mental hazards, including hazards to non-target org-anisms. as prescribed in this subpart. Hazard statements de scribe the type of hazard that may be present, while precautionary state m ents direct or inform the user of ac tions to take to avoid the hazard or mitigate its effects. (b) Location of statements. Environ menta l hazard and precautionary and open flame. Combustible. Do not use or store near heat or open flame. (d) Total release jogger products. (1) A total release Jogger is defined as a pes ticide product in a pressurized con tainer tlesig-ned to automatically re 71 § 156.85 40 CFR Ch. I (7-1-10 Edition) statements may appear on any panel of the label and may be required also in supplemental labeling. The environ men t al hazard stat ements must appear toge ther umler the heading " Environ mental Hazards.' ' Typically the state ments are grouped as a sub-category withi n the "Precautionary State ments" section of the labeling. (c) Type size. All environmental haz ard and precautionary statements must be at least 6 point t y pe . § 156.85 nating insects, the label must bear ap propriate label cautions. (6) If a product is intended for out door use other than aquatic applica t ions, the label must bear the caution, ' ·Keep out of lakes, ponds or streams. Do not. contaminate water by cleaning of equipment or disposal of wastes." Subparts F-G [Reserved] Subpart H-container Labeling Non-target organisms. SOURCE: 71 (a) Requirement. Where a hazard ex ists to non-target organisms, EPA may require precautiona r y statements of the nature of the hazard a nd the appro priate precautions to avoid potential accident, injury, or damage. {b) EJ:amples. The statements in this paragraph illustrate the types of haz ard statements that EP A may require and the circumstances under which they are typically required. Th ese statements are not comprehensive; other statements may be required if more appropriate to the formulation or use. {1) If a pesticide intended for outdoor use contains an active ingredient with a mammalian acute oral LDso of 100 mg/kg or less, t he statement, ·'This pesticide is toxic to wildlife" is re quired. (2) If a pesticide intended for outdoor use eontains an active ingredient with a fish acute LCso of 1 ppm or less, the statement, ' ·This pesticide is toxic to fish· ' is required. {3) If a pesticide intended for outdoor use contains an active ingredient with an avian acute oral LD 50 of 100 mg/kg or less, or a subacute dietary LCso of 500 ppm or less, the statement, "This pesticide is toxic to wildlife" is re quired. (4) If either accident history or field studies demonstrate that the use of the pesticide may r esult in fatality to birds, fish or mammals, the statement, ·'Th is pesticide is extremely toxic to wildlife (fish)" is required. (5) If a product is intended for or in vol ves foliar application to agTicul tural crops, forests or shade trees , or mosquito abatement treatments, and contains a pesticide toxic to polli ~'R 47420, Aug. 16. 2006. unless otherwise noted. § 156.140 Identification of container types. For products other t han plant-incor porated protectants, the following statements, as applicable, must be placed on the label or container. The information may be located on any part of the container except the clo sure. If the statements are placed on the container, they must be durably marked on the container. Durable marking includes, but is not limited to etching, embossi ng, ink jetting, stamp ing, heat stamping, mechan ically at taching a plate, molding, or marking with durable ink. (a) Nonrefillable container. For non refillable containers, the stat;ements in paragraphs (a)(l ) through (a)(4) of this section are required except as provided in paragraphs (a)(5), (c), (d), and (e) of this section. If placecl on the label , the statements in paragraphs (a)(l) through (a)(3) of this section must be under an appropriate heading under the heading ·' Storage and Disposal. " If any of the statements in paragra phs (a)(l) through (a)(3) of this section are placed on the container, an appropriate refer ral statement such as "See container for recycling [or other descriptive word] information. " must be placed on the label under the heading "Storage and Disposal. " (1) Statement identifying a nonrefillable container. The following phrase is re quired: "Nonrefillable container." (2) Reuse statement. One of the fol lowing statements is required. Prod ucts with labels that allow household/ residential use must use the statement in paragraph (a)(2)(i) or (a.)(2)(iii) of this section. All other products must 72 Environmental Protection Agency § 156.140 use the statement in paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section. (i) " Do not reuse or refill this con tainer. " (ii) " Do not reuse this container to hold materials other than pesticides or dilute pesticides (rinsate). After emptying and cleaning, i t may be al lowable to temporarily hold rinsate or other pesticide-related materials in the container. Contact your state regu latory a gency to determine allowable prac t ices in your state. " (iii ) The follo wing statemen t may be used if a product is ' Teady-to-use" ancl its directions for use allow a different product (that is a similar, but con centrated formulation) to be poured into the container and diluted by the end user: "Do not reuse or refill this container unless the directions for use allow a different (concentrated) pr od uct to be cliluted in the container." (5) Exemptions. Pesticide products in t he following t ypes of nonrefillable containers, and their packaging, are exempt from the requirements in para graphs (a)(1) and (a)(2) of this section: (i) Aerosol cans. (ii) Devices as defined in § 152.500 of this chapter. (iii) One-time use caulking tubes and other one-time use squeezable tube containers for paste , gel, or other simi lar substances. (iv) Foil packets for water soluble packaging, repellent wipes , and other one-time use products. (v) One-time use portion control packets, such as polyethylene sleeve packages, or rodenticide placepacks. (vi) One-time use bait stations. (vii) One-time use cages for repellent or trapping strips. (viii) Pet collars or animal ear tags, such as cattle ear tags. (ix) One-time use semiochemical dis persion devices. (x) Any container that is destroyed by t he use of the product contained. (xi) Any container that would be de stroyed if reuse of the cont ainer were attempted. (b) Refillable containel". F or refillable containers, one of the following state ments is required, except as provided in paragraphs (c), (d), and (e) of this sec tion. If placed on the label , the state ment must be under the heading " Storage and Disposal." If the state ment is placed on the container, an ap propriate referral statement, such as "Refilling limitations are on the con tainer." must be placed under the heading " Storage and Disposal. " (1) " Refillable Container. Refill this container with pesticide only. Do not reuse this container for any other pur pose." (2) " Refillable Container. R efill this container with [common chemical name] only. Do not reuse this container for any other purpose." (c) Modification. EPA may, on its own initiativ e or based on data or informa tion submitted by any pemon, modify or waive the requirements of this sec tion or permit or re quire alternative labeling statements. (d) Exemption for articles. Pesticidal articles that are not exempted from FIF RA regulation by § 152.25(a) of this (3) Recycl'ing or reconditioning state ment. One of the following statements is required: (i ) "Offer for recycling if available." (ii) " Once cleaned, some agricultural plastic pes ticide containers can be taken to a container coll ection site or picked up fo r recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact [a pesticide container recycling organiza tion] at [phone n umber] or [web site]. For example, this statement could be "Once cleaned, some agricultural plas tic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manu facturer or contact the Ag Container Recycling Council (ACRC) at 1-877-952 2272 (toll-free) or www.acrecycle.org. •· (iii) A recycling statement approved by EPA and published in an EPA docu ment, such as a Pesticide Registration Notice . (iv) An alternative recycling state ment that has been reviewed and ap proved by EPA. (v) "Offer for reconditioning if appro priate." (4) Batch code . A lot number, or other code used by the registrant or producer to identify the batch of the pesticide product which is distributed and sold is required. 73 § 156.144 40 CFR Ch. I (7-1-10 Edition) chapter are exempt from the require ments of this section. (e) § 156.146 Residue removal instructions for nonrefillable containers-rigid containers with dilutable pes ticides. Exemption for tmnsport vehicles. Transport vehicles are exempt from the requirements of this section. The label of each dilutable (liquid or solid) pesticide product packaged in a rigid nonrefillable container must in clude the following residue rem oval in structions as appropriate. [71 FR 47420 , Aug. 16. 2006. as amended at 73 FR 64224 , Oct. 29 , 2008] § 156.144 Residue tions-general. removal instruc (a) Timing of the residue rem oval proce dure . One of the following statements (a) General . Except as provided by paragraphs (c) through (g) of this sec tion, the label of each pesticide prod uct must include the applicable in structions for removing pesticide resi dues from the container prior to con tainer disposal that are specified in § 156.146 and § 156.156. 'rhe residue re moval instructions are required for both nonrefillable and refillable con tainers. must immediately precede t he instruc tions required in paragraph (b) of this section and must be consistent with the instructions in paragraphs (b) and (c) of this section: (1) "Clean container promptly after emptying. " (2) "Triple rinse or pressure rinse container (or equivalent) promptly after emptying. " (3) " Triple rinse container (or equiva lent) promptly after em ptyi ng. " (b) Triple rinse instructions. The label of each dilutable pesticide product packaged in rigid nonrefillable con tainers must include one of the fol lowing sets of instructions. (1) For liquid dilutable pesticide products in containers small enough to shake, use the following instructions: "Triple rinse as follows: Empty the re mammg contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip . Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times." (2) For solid dilutable pesticide prod ucts in containers small enough to shake, use the following- instructions: "Tr iple rinse as foll ows: Empty the re mammg contents into application equipment or a mix tank. Fill the con tainer 114 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow be gins to drip. Repeat this procedure two more times. " (3) For containers that a r e too larg·e to shake, use the following instruc tions: ' ·Triple rinse as foll ows: Empty r emaining contents into application (b ) Placement of residue remo val state ments. All residue rem oval instructions must be placed under the heading "Storage and Disposal." (c) Exemption for residential/household use products. Residential/household use pesticide products are exempt from the residue removal instruction require ments in this section through § 156.156. (d) Modification. EP A may, on its own initiative or based on data submitted by any person, modify or waive the re quirements of this section throug·h §156.156, or permit or require alter native labeling statements. (e) Exemption for gases . Pesticide products that are g·aseous at atmos pheric temperature and pressure are exempt from the residue removal in struction requirements in this section through § 156.156. (f) Exemption tor articles. Pesticidal articles that are not exempted from FIFRA regulation by § 152.25(a) of this chapter are exempt from the residue removal instruction requirements in this section through § 156.156. (g) Exemption for transport vehicles. Transport vehicles are exempt from the requirements in this section through § 156.156. [71 FR 47420. Aug. 16, 2006, as amended at 73 FR 64224. Oet. 29. 2008] 74 Environmental Protection Agency equipment or a mix tank. F.i ll the con tainer 1/4 full with water. Replace and tig-hten closures. Tip container on its side and roll it back and forth, ensur ing- at least one complete revolution, for 30 seconds. Stand the container on its end and tip it back and forth sev eral times. Turn the container over onto its other end and tip it back and forth several times. Empty the rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Repeat this proceclure two more times. " (c) Pressure rinse instr ucti ons . The label of each dilutable pesticide prod uct packaged i n rig-id nonrefillable con tainers may include one of the fol lowing sets of instructions, and one of them must be used if the statement in paragraph (a)(2) of this section is used. If one of these statements is included on the label , it must immediately fol low the triple rinse instructions speci fied in paragraph (b) of this section. (1) For liquid dilutable pesticide products, use the following label in struction: ' 'Pressure rinse as follows: Empty the remaining contents into ap plication equipment or a mix tank and continue to drain for 10 seconds after th e flow begins t o drip. Hold container upside down over appli cation equip ment or mix tank or collect rinsa.te for later use or disposal. Insert pressure rinsing n ozzl e in the side of the con tainer. and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip." (2) For solid dilutable pesticide prod ucts, use the following label instruc tion: " Pressure rinse as follows: Empty the remaining contents into applica tion equipment or a mix tank. Hold cont ainer upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 P SI for at least 30 seconds . Drain for 10 seconds after the flow beg-ins to drip. ,. (d) No n -water diluent. (1) A registrant who wishes to require users to clean a container with a diluent other than water (e .g., solvents) must submit to EP A a written request to modify the residue removal instructions of this section. The registrant may not dis tribute or sell the pesticide with the .) § 156.156 modified residue removal instructions until EPA approves the request in writ ing. (2) The regi strant must indicate why a non-water diluent is necessary for ef ficient residue removal , and m ust pro pose residue removal instructions and disposal instr uctions that a re appro priate for the characteristics and for mulation of the pesticide product and non-water diluent. The proposed res idue removal instructions must iden tify the diluent. If the Directions for Use permi t the application of a mix ture of the pesticide and the non-water diluent, the instructions may allow the rinsate to be added to the application equipment or mix tank. If the Direc tions for Use do not identify the non water diluent as an allowable addition to the pesticide , the instructions must require collection and storage of the rinsate in a rinsate collection system. (3) E P A may approve the request if EPA finds that the proposed instruc tions are necessary and appropriate. § 156.156 Residue removal in structions for refillable containers. The label of each pesticide product packaged in a refillable container must include the residue r em oval instruc tions in this section. Instructions must be given for all pesticide products that are distributed or sold in refillable con tainers, including those that do not re quire dilution prior to application. (a) Timing of the residue removal pTOce dure . One of the following statements must immediately precede the instruc tions required in paragraph (b) of this section and must be consistent with the instructions in paragraph (b) of this section: (1) "Cleaning the container before final disposal is the responsibility of the person disposing· of the container. Cleaning· before refilling is t he respon sibility of the refiller." (2) '·Pressure rinsing the container before final disposal is th e responsi bilit y of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller." (b) Residue removal instTucUons prior to container disposal. (1) Instructions for clea ning each refillable container prior to disposal are required. The residue 75 § 156.159 40 CFR Ch. I (7-1-10 Edition) removal instructions must be appro priate for the characteristics and for mulation of the pesticide product and mus t be adequate to protect human health and the environment. (2) Subject to meeting the standard in paragraph (b)(l) of this section, the statement on r esidue removal instruc tions could incl ude any one of the fol lowing : ( i ) The refilling residue rem oval pro cedure developed by the registrant for the pesticide product. (ii) Standard industry practices for cleaning refillable containers. (iii) For pesticides that require dilu tion prior to application, the following statement: " To clean the container be fore final disposal, empty the remain ing contents from this contain er into application equipment or a mix tank. F'ill the container about 10 percent full with water. Agitate vig·orously or re circulate water with the pump for 2 minutes. Pour or pump rinsate into ap plication equipment or rinsate collec tion system. R epeat this rinsing proce dure two more t imes." (iv) Any other statement the reg istrant considers appropriate. § 156.200 Scope and applicability. (a) Scope. (1) This subpart prescribes statements that must be placed on the pesticide label and in pestieide label ing. These statements incorporate by reference the Worker Protection Standard, part 170 of this chapter. The requirements addressed in these state ments are design ed to reduce the risk of illness or injury resul t ing from workers· and pesticide handlers' occu pational exposures to pesticides used in the production of a gricultural plants on agricultural establishments as de fined in §170.3 of this chapter. These statements refer to specific workplace practices designed to reduce or elimi n ate exposure and to respond to emer gencies that may arise from the expo sures that may occur. (2) This subpart prescribes interim requirements that must be placed on the pesticide label and in pesticide la beling. These interim requirements pertain to restricted-entry intervals, personal protective equipment, and no tification. On a case-by-case basis, these interim requirements will be re viewed and may be r evised during re registration or other agency review § 156.159 Compliance date. processes. Any pesticide product released for (b) Applicability. (1) The requirements shipment by a registrant after August of this subpart apply to each pesticide 16, 2010 must bear a label that complies product that bears directions for use in with §§ 156.10(d)(7) , 156.10(f) , the production of any agricultural 156.10(i)(2)(ix), 156.140, 156.144, 156.146, plant on any agricultural establish and 156.156. ment as defined in § 170.3 of this chap ter, or whose labeling reasonably per [73 FR 64224, Oct. 29. 2008) mits such use. J<:r'FEC'TIVE DATF: N 01'E: At 75 FR 33708. June (2) The requirements of t his subpart 15. 2010. § 156.159 was r e vi sed, effec tive Aug. do not appl y to a product that bears di 16. 2010. !<'or the convenience of the user. the revised text is set forth as foll o ws : rections solely for uses excepted by § 170.202(b) of this chapter. § 156.159 Compliance date. {c) Effective dates . No product to Any pesticide product released for ship which this subpart applies shall be dis ment lly a registran t after December 16, 2010 tributed or sold without amended la must bear a l abel that complies with §§ beling by any regi strant after April 21, 156.10(d)(7). 156.10([), 156.10(i )(2)(ix). 156.140. 1994, or by any person after October 23, 156.144 , 156.146 and 156.156. 1995. Subparts 1- J [Reserved] Subpart K- Worker Protection Statements SOURCE: 57 FR 38146. Aug. 21, 1992, unless otherwise noted. [57 FR 38146, Aug . 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008] § 156.203 Definitions. Terms in t his subpart have the same meanings as t hey do in the Federal In secticide, Fungicide, a nd Rodenticide 76 § 156.206 Environmental Protection Agency Act, as amended. In addition, the fol lowing terms, as used in this subpart, shall have the meanings stated below: Fumigant means any pesticide prod uct that is a vapor or gas or forms a vapor or gas on application and whose method of pesticidal action is t hrough the gaseous state. Restricted-entry interval or REI means the time after the end of a pesticide ap plication during which entry to the treated area is restricted. [57 F' R 38146. Aug. 21. 1992. as amencled at 73 FR 75596. Dec. 12. 2008] § 156.204 Modification and w a iver of requirements. (a) Modification on Special Review. If the Agency concludes in accordance with § 154.25(c) of this chapter that a pesticide should be placed in Special Review because the pesticide meets or exceeds the criteria for human health effects of § 154.7(a)(1)(2) or (6) of this chapter, the Agency may modify the personal protective equipment required for handlers or early-entry workers or both, the restr icted-ent r y intervals, or the notification to workers require ments . (b) Other modifications. The Agency, pursuant to this subpart and authori ties granted in FIFRA sections 3, 6, and 12, may, on its initiative or based on data submitted by any person, modify or waive the requirements of this sub part, or permit or require alternative labeling statements. Supporting data may be either data conducted accord ing to Subdivisions U or K of the Pes ticide Assessments guidelines or data from medical, epidemiological, or health effects st udies. A registrant who wishes to modify any of the statements required in §§ 156.206, 156.208, 156.210, or 156.212 must submit an application for amended registration unless specifi cally directed othe rwise by the Agency. [57 F'R 38146. Aug. 21. 1992, as amendecl at 73 FR 75596, Dec. 12. 2008] § 156.206 General statements. (a) Application restrictions. Each prod uct shall bear the statement: ·'Do not apply this product in a way that will contact workers or other persons, ei ther directly or through drift. Only protected handlers may be in the area during application." This statement shall be near the beginning of the DI RECTIONS FOR USE section of the la beling under the heading AGRICUL TURAL USE REQUIREMENTS. (b) 40 CPR, part 170 reference statement. (1) Each product shall bear the ref erence statement: "Use this product only in accordance with its labeling and with the Worker Protection Stand ard, 40 CFR part 170. " This statement shall be placed on the product label under the heading AGRICULTURAL USE REQUIREMENTS . (2) Each product shall bear the state ment: " This standard contains require ments for the protection of agricul tural workers on farms, forests, nurs eries, and greenhouses, and handlers of agricultural pesticides. It contains re quirements for training, decontamina tion, notification, and emergency as sistance. It also contains specific in structions and exceptions pertaining to the statements on this label [in this la beling] about [use any of the foll owing that are applicable) personal protective equipment, restricted-entry inter val, and notification to workers." These statements shall be placed imme Lliately following the reference state ment required by paragraph (b)(1) of this section, or they shall be placed in the supplemental product labeling under the heading AGRICULT URAL USE REQUIREMENTS. (3) If the statements in paragraph (b)(2) of this section are included in supplemental labeling rather than on the label of the pesticide container, the container label must contain this statement immediately following the statement required in paragraph (b)(1) of t his section: "Refer to supplemental labeling entitled AGRICULTURAL USE REQUIREMENTS in the DIREC TIONS FOR USE section of the label ing for information about this stand ard. " (4) If the statements in paragTaph (b)(2) of this section are included in supplemental labeling, they must be preceded immediately by the state ment in paragraph (b)(1) of this section under the heading AGRICULTURAL USE REQUIREMENTS in the labeling . (c) Product-type identification. the product organophosphate 77 contains (i. e., (1) If an an § 156.208 40 CFR Ch. I (7-1-10 Edition) organophosphorus ester that inhibits cholinesterase) or an N-methyl carba mate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall be a ssociated with the pr oduct name or product-type identification or shall be in the STATEMENT OF PRAC TICAL TREATMEN'r or FIRS'r AID section of the label. (2) If the product is a fumigant , the label shall so state. The identification shall appear: (i) As part of the product name; or (ii ) Close to the product name, as part of the product-t y pe identification or as a separat e phrase or sentence. (d) State r estrictions. Each product shall bear the stat ement: " For any re quirements specific to your State, con sult the agency in your State respon sible for pesticide regulation. " This statement shall be under the heading AGRICULTURAL USE REQUIR E MENTS in the labeling. (e) Spanish warning statements. If the product is classified as toxicity cat egory I or toxicity category II accord ing to the criteria in §156.62, the signal word shall appear in Spanish in addi tion to English followed by the state ment, " Si Usted no entiende la etiqueta, busque a alguien para que se la explique a Usted en detalle. (If you clo not unclerstand the label, find some one to explain it to you in detail. )" T he Spanish signal word "PELIGRO " shall be used for products in toxicity cat egor y I , and the Spanish signal word "AVISO" shall be used for products in toxicity category II. These statements shall appear on the label close to t he English signal word. a pplicable to all registered uses of the product on agricultural pla nts, the re stricted-entry interval for the product shall appear as a continua tion of the statement required in paragraph (a) of this section and shall appear as fol lows : " of X h ours" or " of X days " or " until the acceptable exposure level of X ppm or mgfm3 is reached. " (2) If different restricted-entry inter vals have been established for some crops or some uses of a product, the re stricted-entry statement in paragraph (b)(1) of this section shall be associated on the labeling of the product with the directions for use for each crop each use to which it applies, immediately preceded or immediately followed by the words " Restricted-entry interval" (or the letters "REI" ). (c) Restricted-entry interval based on t oxicity of active ingredient~(l) Deter mination of toxicity category. A re (a) Requirement. Each product with a restri cted-entry interval shall bear the foll owing statement: " Do not enter or allow worker entry into treated areas during the re st ricted-entry interval (REI). " This statement shall be under the heading AGRICUL TURAL USE RE QUIREMENTS in the labeling. stricted-entry interval shall be estab lished based on the acute toxicity of the active ingredients in the product. For the purpose of setting the re stricted-ent r y interval, the toxicity category of each active ingredient in the product shall be determined by comparing· the obtainable data on the acute dermal toxicity, eye irritation effects, and skin irritation effects of the ingredient to the criteria of§ 156.62. The most toxic of the applicable tox icity categories that are obtainable for each active ingredient shall be used to determine the restricted-en try interval for that product. If no acute dermal toxicity data are obtainable , data on acute oral toxicity also shall be consid ered in this comparison. If no applica ble acute toxicity data are obtainable on the active ingredient, t he toxicity category corresponding to the signal word of any registered man ufacturing use product that is the source of the act ive ingredient in the end-use prod uct shall be used. If no acute toxicity dat a are obtainable on the active ingre dients and no toxicity category of a registered manufacturing-use product is obtainable, the toxicity category of the end-use product (corresponding to the signal word on its labeling) shall be used. (b) Location of specific restricted-entry interval statements. (1) If a product has (2) Bestricted-entry interval for sole a c tive ingredient woducts. (i) If the prod one specific restricted-entry interval uct contains only one active ingredient [57 FR 38146, Aug. 21. 1992, a s amended a t 58 F R :34203 , June 23, 1993; 73 F'R 75596 , Dec. 12. 2008] § 156.208 Restricted-entry statements. 78 Environmental Protection Agency § 156.210 and it is in toxicity category I by the criteria in paragraph (c)(1) of this sec tion, the restricted-entry interval shall be 48 hours. If, in addition, the active ingredient is an organophosphorus ester that inhibits cholinesterase and that may be applied outdoors in an area where the average annual rainfall for the application site is less than 25 inches per year, the foll owi ng state ment shall be added to the restricted entry interval statement: "(72 hours in outdoor areas where average annual rainfall is less than 25 inches a year)." (ii) If the product contains only one active ingredient and it is in toxicity category II by the criteria in paragraph (c)(1) of this section, the restricted entry interval shall be 24 hours. (iii) If the product contains only ac tive ingredients that are in toxicity category III or IV by the criteria in paragraph (c)(1) of this section , the re stricted-entry interval shall be 12 hours. (2) Product-specific restr icted-entry intervals established for pesticide prod ucts or pesticide uses that are not cov ered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling. (3) Restricted-entry interval for multiple active ingredient pro ducts. If the product § 156.210 (f) Existing inteTim restrict ed-entry in tervals. (1) An interim restricted-entry interval established by the Agency be fore the effective date of this subpart will continue to apply unless a longer restricted-entry interval is required by paragraph (c) of this section . (2) Existing interim restr icted-entry intervals established by the Agency for pesticide products or pesticide uses not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICUL TURAL USE REQUIREME NTS in the labeling·. [57 FR 38146, Aug. 21, 1992, as amended at 58 Fl~ 34203. June 23, 1993; 72 FR 61028, Oct. 26. 2007; 73 ~'R 75596, Dec. 12, 2008] Notification-to-workers state ments. (a) Requirement. Each product that contains more than one active ingre dient, the restricted-entry interval (in cluding any associated statement con cerning use in arid areas under para graph (c)(2)(i) of this section) shall be based on the active ingredient that re quires the longest restricted-entry in terval as determined by the criteria in this section. (d) E.rception for fumigants. The cri teria for determining restricted-entry intervals in paragraph (c) of this sec tion shall not apply to any product that is a fumigant. For fumigants, any existing restricte d-entry interval (hours, days, or acceptable exposure level) shall be retained. Entry restric tions for fumigants have been or shall be established on a case-by-case basis at the time of registration, reregistra tion, or other Agency review process. meets the requirements of paragraph (b) of this section shall bear the post ing and oral notification statements prescribed below. The statements shall be in the DIRECTIONS FOR USE sec tion of the labeling under the heading AGRICULTURAL USE REQUIRE MENTS. ( b ) Notification to workers of pesticide application. (1) Each produet that con tains any active ingredien t classified as toxicity category I for either acute dermal toxicity or skin irritation po tential under the criteria. in § 156.62 shall bear the statement: "Notify workers of the application by warning them orally and by posting warning sig-ns at entrances to treated areas." If no acute dermal toxicity data are ob tainable, data on acute oral toxicity of the active ingredient shall be consid ered instead. If no data on acute der mal toxicity, skin irritation potential, or acute oral toxicity are obtainable on the active ingredient, the toxicity cat egory corresponding to the signal word of any reg·istered manufacturing-use product that is the source of the active ingredient in the end-use pr oduct shall be used. If none of the applicable acute (e) EJ:isting pr oduct-specific restricted entry intervals. (1) A procluct-specific re stricted-entry interval, based on data collected in accordance with § 158.1070 or § 161.390 of t his chapter and Subdivi sion K of the Pesticide Assessment Guidelines, shall supersede any re stricted-entry interval applicable to the product under paragraph (c) of this section. 79 § 156.212 40 CFR Ch. I (7-1-1 0 Edition) toxicity data are obtainable on the ac tive ingredient and no t oxicity cat egory of the registered manufacturing use product is obtainable, the toxicity category of the end-use product cor responding to the product's sig·nal word shall be used. (2) Each product that is a fumigant and is registered for use in a green house (or whose labeling allows use in a greenhouse) shall bear the statement: "For greenhouse applications, notify workers of the application by warning them orally and by posting warning signs outside all entrances to the greenhouse ." [57 J<'R 38146, Aug. 21 , 1992. as amended at 58 FR 3420:1. June 23 , 1993; 73 FR 75596, Dec. 12, 2008] § 156.212 Personal protective equip ment statements. (a) Requirement. Each product shall bear the personal protective equipment statements prescribed in paragraphs (d) through (j ) of this section. (b) Exceptions. (1) If personal protec tive equipment were required for a product before the effective date of this subpart, the existing requirements shall be retained on the labeling wher ever they are more specific or more protective (as specified in EPA guid ance materials) than the requirements in the table in paragraph (e) of this sec tion. (2) Any exist ing labeling statement that prohibits the use of gloves or boots overrides the corresponding re quirement in paragraph (e) of this sec tion and must be retained on the label ing. (3) If the product labeling contains uses that are not covered by part 170 of this chapter, the registrant may adopt the personal protective equipment re quired in this section for those uses. However, if the personal protective equipment required in this section would not be sufficiently protective or would be onerously overprotective for uses not covered by part 170 of this chapter, the registrant must continue to apply the existing personal protec tive equipment requirements to those uses. The labeling must indicate which personal protective equipment require ments apply to uses covered by part 170 of this chapt er and which personal pro tective equipment requirements apply to other uses. (c) Location of peTsonal protective equipment statements-(1) Per sonal pTo tective equipment statements for pesticide handlers. Personal protective equip ment statements for pesticide handlers shall be in the HAZARDS TO HUMANS (AND DOMESTIC ANIMALSl section of the labeling. The required statements may be combined to avoid redundancy as long as the requirements and condi tions under which they apply are iden tified. (2) Personal protective equipment statements for early-entry workers. Personal protective equipment state ments for early-entry workers shall be placed in the DIRECTIONS FOR USE section of the labeling under the head ing AGRICULTURAL USE REQUIRE MENTS and immediately after the re stricted-entry statement r equired in § 156.208(a). (d) Personal protective equipment state ments for pesticide handlers. (1) T he table in paragraph (e) of this section specifies minimum requirements for personal protective equipment (as de fined in § 170.240 of this chapter) and work clothing for pesticide handlers. This personal protective equipment re quirement applies to any product that presents a hazard through any route of exposure identified in the table (acute dermal toxicity, skin irritation poten tial. acute inhalation toxicity, and eye irritation potential) . (2) The requirement for personal pro tective equipment is based on the acute toxicity category of the end-use prod uct for each route of exposure as de fined by § 156.62. If data to determine the acute dermal toxicity or the acute inhalation toxicity are not obtainable, the acute oral toxicity shall be used as a surrogate to determine the personal protective equipment requirements for that route of exposure . If data to deter mine the acute toxicity of the product by a specific route of exposure (includ ing acute oral toxicity in lieu of acute dermal or acute inhalation toxicity) are not obtainable, the toxicity cat egory corresponding to the signal word of the end-use product shall be used to 80 Environmental Protectio n Agency § 156.212 determine personal protective equi p ment requirements fo r that route of ex posure. If the signal word is "CAU TION, " toxicity category III will be used. (3) The minimum personal protective equipment and work clothing require ments specified in this section shall be included in a statement such as the fol lowing: "Applicators and other han dlers must wear: (body protection statement); (glove statement, if appli cable); (footwear statement, if applica ble); (protective eyewear statement, if applicable); (respirator statement, if applicable)." The format of statements given in this paragraph is optional , but it is recommended for clarity. (e) Summary of personal protective equipment requirements . The following table 1 summarizes the personal pro tective equipment requirements by route of exposure and toxicity cat egor y : TABLE 1- MIN IMUM P ERSONAL PROTECTIV E EQUI PMENT ( PPE) AND WORK CLOTHING FOR HANDLING ACTIVITIES Toxicity Category of End -Use Product Route of Exposure I Dermal T oxicity or Sk in lrritation Po tentia lt Coveralls worn over long-sleeved shirt and long pants Socks Chemica l-resistant footwear Chemical-resis tant gloves2 IV Ill II Coverall s worn over short -sleeved shirt and short pants Socks Chemical-resistant footwear Chem ical-resistant gloves 2 Long-sleeved shirt and long pants Long-sleeved shirt and long pants Socks Shoes Socks Shoes Chemical-resistant gloves 2 No minimum 4 Inhalation Toxicity Respiratory protection device3 Respiratory protection device3 No minimum4 No minimum 4 Eye Irritation Polentia l Protective eyewear Protective eyewear No minimum4 No minimum 4 If dermal toxicity and skin irritation potenlial are in different toxicity categories, protection shall be based on the more toxic (lower numbered) cat egory. 2 For labeling language for chemical- resistant gloves, see pa ragraph (f) of this section. 3 For labeling language fo r respiratory protection device. see paragraphs (g) and (h) of this section. 4 Although no minimum PPE is required by this section for this tox icity category and route of exposu re, the Agency may re quire PPE on a product-specific basis. 1 (f) Chemical-resistant _gloves labeling statements for pestici de handlers. If the table in paragraph (e) of this section indicates that chemical-resistant gloves are required, the glove state ment shall be as specified in parag-raph (f)(2), <3) , (4), or (5) of this section. (1) Exception . The registrant shall specify a glove t y pe other than that se lected through the cri teria in para graphs (f)(2) through (5) of this section if information available to the reg- istrant indicates that such a glove type is more appropriate or more protective than the glove type specified in this section. The statement must specify the particular types of chemical-resist ant g-love (such as nitrile, butyl, neo prene , and/or barrie r-laminate). (2) Solid fonnulations. F'or products formulated and applied as solids or for mulated as solids and diluted solely with water for application, the glove statement shall specify: " waterproof gloves.·· (3) Aqueous-based f ormu l ations. For products formulated and a pplied as a water-based liquid or formulated as a water-based liquid and diluted solely with water for application, the glove statement may specify: "waterproof gloves" instead of the statement in paragraph (f)(4) of this section. (4) Other liquid f or mulations. For prod ucts formulated or diluted wi th liquids other than water, the glove statement shall specify: "chemical-resistant (such as nitrile or butyl) g·loves. " (5) Gaseous f ormulations and applica tions. F'or products formulated or ap plied as gases, any existing glove state ment established before the effective dat e of this subpart, ineluding any glove prohibition statement, will con tinue to apply. If no g-love statement or glove prohibition now exists, the glove 81 § 156.212 40 CFR Ch. I (7-1-10 Edition) statement shall specify "chemical-re a gas (space and soil fumigants) and sistant (such as nitrile or butyl) that may be used outdoors, the res gl oves." piratory protection statement shall be: (g) Ex·isting respirator requirement for " F or ha ndling activities outdoors, u se pesticide handlers on product labeling ei t her a respirator with an organic (l) General requirement. If a statement vapor-removing cartridge with a placed on a product's labeling before prefilter approved for pesticides the effective date of this subpart indi (MSHA/NIOSH approval number prefix cates that respiratory protection is re TC-23C), or a canister approved for pes quired, that requirement for protection ticides (MSHA/NIOSH approval number shall be retained . 'The statement must prefix TC-14G)." specify, or be amended to specify, one (iii) Gases used in enclosed areas. For of t he following respirator t ypes and products that are formulat ed or applied the appropriate MSHA/NIOSH approval as a gas (space and soil fumi gants) and number prefix: t hat may be used in greenhouses or (i) Dust/mist filtering respirator with other enclosed areas, the respiratory MSHA/NIOSH/ approval number prefix protection statement sha ll specify: 'l'C-21C; or " For handling activities :in enclosed (ii) Respirator with an organic-vapor areas, use either a supplied-air res removing cartri dge and a prefilter ap pirator with MSHA/NIOSH approval proved for pesticides with MSHA/ number prefix TC-19C, or a self-con NIOSH approval number prefix 'l'C-23C tained breathing apparatus (SCBA) or with a canister approved for pes with MSHA/NIOSH approval number ticides with MSHA/NIOSH approval TC-13F. " number prefix 'l'C-14G; or (iv) Solids. For products that are for (iii ) Supplied-air respirator with mulated and applied as soli.ds, the res MSHA/NIOSH approval number prefix piratory protection statement shall 'l'C-19C or self-contained breathing ap specify: "dust/mist filtering respi rator paratus (SCBA) with MSHA/NIOSH ap (MSHA/NIOSH approval number prefix TC-21C). " proval number 'l'C-13F. (v) L iquids in toxicity category I . For (2) Respirator type already specified on labeling . If the existing r espirator y pro products that are formulated or applied tection requirement specifies a res as liquids , and, as formulated, have an pirator type , it shall be retained. 'The acute inhalation toxicity (or its surro respirator statement must be revised , gate as specified in paragraph (d)(2) of if ne cessa ry, to conform to the wording this section) in category I, the res in paragraph (g)(l) of this section. piratory protection statement shall (3) Respirator type not already specified specify: "either a respirator with an or on labeling. If the existing r espi ratory ganic-vapor-removing cartridge with a protection requirement on product la prefilter approvecl for pesticides beling does not specify a respirator (MSHA/NIOSH approval number prefix t ype as listed in paragraph (g)(l) of this TC-23C), or a canister approved for pes section. the specific respirator type ti cides (MSHA/NIOSH approval number shall be that r equired in the criteria in prefix 14G). ·· paragraphs (g)(3)(ii) through (vi) of this (vi) Liquids in toxicity category II. For section. products that a re formulated or applied (i) £.~·ception. The· registrant shall as liquids, and, as formulated, have a n specify a different type of respiratory acute inhalation toxicity (or its surro protection device if information, such g-ate as specified in paragraph (d)(2) of as vapor pressure value, is available to this section) in category II, the res the registrant to indicate that the type piratory protection statement shall of respiratory protection device se specify: " For handling activities dur lected through the criteria in para ing (select uses applicable to the prod graphs (g)(3)(ii) through (vi) of this sec uct: airblast, mistblower, pressure tion would not be adequately protec greater than 40 p.s.i. with fine droplets, tive, or might increase risks to the smoke, mist , fog, aerosol or direct overhead) exposures, wear ei t her a res user unnecessarily. (ii) Gases applied outdoors. For prod pirator with an organic-vapor-remov ucts that are formulated or applied as ing cartridge with a prefilter approve d 82 Environmental Protection Agency for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix 14G). For all other exposures, wear a dust/mist fil tering respirator (MSHA/NIOSH ap proval number prefix TC-21C)." (h) New respirator requirement estab lished for pesticide handlers in this part (1) General requirement. If the table in Pt. 157 (3) If any t ype of equipment other than the product container may be used to mix, load, or apply the product, and there is no requirement for a chemical-resistant protective suit, the following statement shall be included: " For Cleaning Equipment: add a chem ical-resistant apron." (j) Personal protective equipment for early-entry workers . This paragraph specifies minimum requirements for personal protective equipment (as de fined in §170.240 of this chapter) and work clothing for early-entry workers. (1) For all pesticide products, add the statement: " For early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, wear: (list the body protec tion, glove, footwear , protective eyewear, and protective headgear, if applicable, statements specified for ap plicators and other handlers, but omit any r espiratory protection state ment)." (2) If the body protection statement in t he personal protective equipment requirement for handlers specifies a long-sleeved shirt and long pants, "coveralls" must be specified in the statement of personal protective equip ment for early-entry workers. (3) If there is no statement requiring gloves and no prohibition against gloves for applicators and other han dlers under the heading HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a requirement for "waterproof gloves" in the statement of personal protective equipment for early-entry workers. paragraph (e) of this section indicates a respiratory protection device is re quired, and existing product labeling has no respiratory protection require ment, the registrant shall add a res piratory protection statement t hat specifies a: '·dust/mist filtering res pirator (MSHA/NIOSH approva l num ber prefix TC-21C) ." (2) Exception. 'l'he registrant shall specify a different type of respiratory prot ection device if informat ion. such as vapor pressure value, is available to the registrant to indicate that the type of respiratory protection device re quired in paragraph (h)(1) of this sec tion would not be adequately protec tive or might increase risks to the user unnecessarily. (i) Additional personal protective equip ment requirements for pesticide handlers. In addition to the minimum personal prot ective equipment and work cloth ing requirements given in the table in paragraph (e) of this section , the label ing statement for any product in tox icity category I or II on the basis of dermal toxicity or skin irritation po tent ial (or their surrogate as specified in para graph (d)(2) of this section), shall include the following personal protective equipment instructions, ad ditions, or substitutions as applicable: (1) If the product is not ready-to-use and there is no existing requirement for a chemical-resistant suit, the fol lowing statement shall be included: " Mixers/Loaders: add a chemical-re sistant apron." (2) If the application of the product may r esul t in overhead exposure to any handler (for example , applicator expo sure during ai rblast spraying of or chards or flagger exposure during aer ial application), the following state m ent shall be included: "Overhead Ex posure: wear chemical-resistant head gear." [57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203. June 23. 1993; 73 ~'R 75596, Dec. 12, 2008) PART 157- PACKAGING REQUIRE MENTS FOR PESTICIDES AND DE VICES Subpart A [Reserved] Subpart B-child-Resistant Packaging Sec. 157.20 General. 157.21 Definitions. 157.22 When required . 157.24 Exemptions. 83